February 20, 2019

Zilver PTX Trial 5-Year Mortality Data Corrected in Circulation

February 20, 2019—A correction to the 5-year data publication from Cook Medical's Zilver PTX randomized trial was issued in Circulation (2019;139:e42), revising a key figure and the stated mortality rates for the paclitaxel-eluting stent and the control groups, which were transposed in the 2016 publication. The correction comes less than 1 week after Medtronic issued a statement regarding a forthcoming correction to its mortality figures from the Global registry studying the In.Pact Admiral paclitaxel-eluting balloon.

The Zilver PTX correction states that an incorrect version of Figure 1 of the paper was mistakenly submitted when a high-resolution file was requested during production. Figure 1 depicts the randomization design and patient flow as well as data on mortality, withdraw, and loss to follow-up. Additionally, in the Safety section of the paper, the mortality rate assigned to the primary drug-eluting stent (DES) arm was actually that of the group treated with percutaneous transluminal angioplasty (PTA). In the original publication, the mortality rate in the DES and PTA arms were reported as 10.2% and 16.9%, respectively, whereas in the corrected version, they are reversed: 16.9% in the DES arm and 10.2% in the PTA group.

However, the corrected sentence still reflects that no deaths were deemed to be related to the procedure or device.

The correction can be seen here, and the revised paper here.

Upon request for comment, Cook Medical provided the following statement:

"We discovered that during production of the Circulation article, numbers in one sentence were transposed and an incorrect diagram was used. We submitted a correction in December and Circulation published that correction this week. Although this is a mistake that needed to be addressed, the underlying data that was published in Circulation is correct.

The safety data that we submitted to FDA, other regulatory authorities around the world, and that we use in presentations of 5-year data have been correct. Our patient level data confirms the safety of Zilver PTX, showing no significant difference in mortality between Zilver PTX and uncoated balloons and stents.

We welcome collaborative, transparent conversations about long-term patient outcomes as our industry continually strives for more effective patient care. We have an upcoming analysis of patient level data that will be published soon that confirms the safety of Zilver PTX."

In a LINC 2019 session focusing on the concerns raised by a meta-analysis by Katsanos et al, investigators from key paclitaxel device trials presented new patient-level data asserting no known causal link between paclitaxel and increased mortality. More on the findings of the patient-level analysis can be seen in our coverage of the LINC 2019 session.

For links to all of Endovascular Today's coverage of the continuing discussion regarding paclitaxel in peripheral artery disease, please visit this page.


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